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Oxycodone for RLS

Clinical bottom line

A single small trial provides insufficient evidence to draw any conclusions.


AS Walters et al. Successful treatment of the idiopathic restless legs syndrome in a randomized double blind trial of oxycodone versus placebo. Sleep 1993 16: 327-332.

Clinical trial

This trial was randomised and double blind, and studies 11 patients. The crossover design tested oxycodone titrated to a maximum of 25 mg daily against placebo over two weeks per treatment. Outcomes were subjective assessments of motor restlessness, leg sensations, and drowsiness. Sleep studies were also carried out as the main purpose of the trial.


The mean age of patients was 55 years (range 41-74). Subjective outcomes were all statistically improved on oxycodone. Periodic limb movements while sleeping, sleep arousals, and sleep efficacy were all improved on oxycodone. Adverse events were few and mild, but included constipation and lethargy at higher doses of oxycodone.


There is insufficient evidence to conclusively comment on efficacy or safety of oxycodone for RLS.